Retraining and Control Therapy (ReACT): Sense of Control and Catastrophic Symptom Expectations as Targets of a Cognitive Behavioral Treatment for Pediatric Psychogenic Non-epileptic Seizures (PNES)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Convulsion, Non-Epileptic
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Magic and turbulence task
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.
Detailed Description
PNES participants and their parent come to our laboratory for a baseline visit, 2 follow-up visits and 12 therapy sessions. Participants will complete 2 long-term follow-up visits at 6 months and 12 months after the 12th treatment session via HIPAA-compliant Zoom. Half of the participants will be randomized to receive 2 booster therapy sessions after treatment. Participants must provide EEG results indicating a diagnosis of psychogenic non-epileptic seizures. During the initial visit, participants and their parent will complete several questionnaires assessing demographics, mood and suicidality, relationships with friends and family, as well as past and current PNES symptoms. They will also complete the childhood trauma questionnaire. The treatment targets (sense of control and catastrophic symptom expectations), will be measured by the magic and turbulence computer task and pain tolerance, PCS-C and cortisol response to the CPT, respectively. After completing the CPT, participants will be randomized to receive a pain relief lotion or a pain sensitivity lotion. Participants will then repeat the CPT with the lotion applied to their hand. PNES diaries will be completed to assess PNES frequency over the previous 30 days. The baseline lab visit will last about 3 hours. Saliva will be collected over 3 time points before and after each CPT to measure cortisol response to the CPT. Participants will also collect 2 saliva samples 24 hours later to serve as a baseline outside of the laboratory setting. Participants will also be given a Respironics Actiwatch Spectrum Pro to track sleep and PNES episode severity and frequency for the 1 week between the baseline visit and first ReACT session. All participants will then be scheduled to return in one week for their first of 12 sessions of ReACT. Before beginning the first ReACT session, participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests. This first session will last a maximum of two hours, and the following 11 sessions will be scheduled weekly and will each last one hour. The following 11 sessions are currently conducted via telehealth due to COVID-19. Participants will be mailed another Respironics Actiwatch Spectrum Pro before the 11th therapy session to track sleep and PENS episode severity and frequency for the 2 weeks between the 11th therapy session and the lab visit one week after the 12th treatment session. To assess treatment dose, participants will return for post lab visits one week after the 8th treatment session and 12th treatment sessions to perform tasks and fill out questionnaires completed at baseline. Long-term follow-up at 6 months and 12 months after treatment will also be conducted to assess FS frequency and questionnaires. Participants will complete the Flanker Inhibitory Control and Attention, List Sorting Working Memory, Pattern Comparison Processing Speed, Dimensional Change Card Sort, and Picture Sequence Memory subtests at the lab visit after the 12th treatment session. Each of these sessions will last about 1 to 2 hours. PNES frequency will be measured from 30 days before treatment to 12 months after treatment through PNES diaries completed by the parent and the participant. After treatment, half of the participants will be randomized to receive 2 booster therapy sessions at 3 months and 9 months after the end of treatment. Each of these sessions will last one hour. Healthy controls are matched to participants with PNES based on age (+ or - 1 year), gender, race and family income. Healthy controls and their parent come for a baseline laboratory visit and a follow up visit 13 weeks after the baseline visit. The baseline and follow-up appointments for healthy controls will be identical to the visits for children with PNES.
Investigators
Aaron Fobian
Associate Professor
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •9-18 years old.
- •Diagnosis of psychogenic non-epileptic seizures by a medical doctor using video-EEG.
- •Family member (parent if a minor) willing to participate and that the subject with PNES chooses.
Exclusion Criteria
- •Comorbid Epilepsy
- •Less than 4 PNES per month
- •Other paroxysmal nonepileptic events (e.g. episodes related to hypoxic-ischemic phenomena, sleep disorders or migraine-associated disorders)
- •Participation in other therapy
- •Severe intellectual disability
- •Severe mental illness (delusions/hallucinations)
- •Exclusion for CPT:
- •Blood pressure \>130/80 mmHg for adolescents greater than or equal to 13 years old
- •Either systolic and/or diastolic blood pressure greater than or equal to 95% based on sex and age for children less than 13 years old
Outcomes
Primary Outcomes
Magic and turbulence task
Time Frame: 7 months
Measure of perceived sense of control in response to tasks in which control is manipulated; Greater negative numbers indicate improved understanding of control. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain catastrophizing scale for children- situation specific
Time Frame: 7 months
Measures catastrophic symptom expectations; score ranges from 0-52, higher scores indicate greater levels of pain-related anxiety. Assessment done after performing Cold Pressor Test. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain tolerance (time)
Time Frame: 7 months
Measures catastrophic symptom expectations. Measured by the total time the participant can keep their hand in cool water during the Cold Pressor Test. Shorter time indicates less pain tolerance. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Salivary cortisol response to Cold Pressor Test
Time Frame: 7 months
Measures catastrophic symptom expectations. Measured before and after the cold pressor test. Increased cortisol response indicate increased perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Pain Rating Scale
Time Frame: 7 months
Measures perceived pain severity after the CPT; score ranges from 0-100. Higher scores indicate greater perceived pain severity. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Stroop task
Time Frame: 7 months
Measure of cognitive inhibition and selective attention, higher scores means poorer cognitive inhibition and selective attention. Assessed at baseline visit, 1 week after the 8th therapy session, 1 week, 6 months and 12 months after the final therapy sessions (about 16 months total).
Secondary Outcomes
- PNES Frequency(16 months)
- Pain Catastrophizing Scale for Children (PCS-C)- General(16 months)
- Children's Somatic Symptoms Inventory (CSSI-24)(16 months)
- Anxiety Sensitivity Index (ASI)(16 months)
- Shipley(At baseline)
- Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48)(16 months)
- Sense of Agency Scale(16 months)
- LEVEL 2-Somatic Symptom report adapted from the Participant Health Questionnaire Physical Symptoms(16 months)
- Functional Disability Inventory (FDI)(16 months)
- The Impact on Family Scale(16 months)
- Childhood Trauma Questionnaire(At Baseline)
- The Revised Children's Anxiety and Depression Scale (RCADS)(16 months)
- The Columbia Suicide Severity Rating Scale (C-SSRS)(16 months)
- Healthcare Related Stigma Questionnaire(At Baseline)
- COVID-19 Functional Neurological Disorders (FND) Questionnaire(At Baseline)
- Flanker Inhibitory Control and Attention Subtest(4 months)
- List Sorting Working Memory Subtest(4 months)
- Pattern Comparison Processing Speed Subtest(4 months)
- Dimensional Change Card Sort Subtest(4 months)
- Picture Sequence Memory Subtest(4 months)
- Sleep Duration(4 months)
- Sleep Efficiency(4 months)
- Sleep Onset Latency(4 months)
- Sleep - Bed Time(4 months)
- Sleep - Wake Time(4 months)
- PNES Episode Frequency(4 months)
- PNES Episode Duration(4 months)
- Child Self-Report Tic Questionnaire(16 months)
- Parent Tic Questionnaire(16 months)
- Yale Global Tic Severity Scale(6 months)